Quality of Life in Patients With Inflammatory Bowel Disease Clinical Trial
Official title:
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
| Verified date | December 2013 |
| Source | Technische Universität München |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life
compared to healthy adults. This is due to the chronic course of disease accompanied with
diarrhea, stomach pains but also with psychological stress.
It is known that physical education may improve course of disease and quality of life in a
multitude of diseases. These include coronary heart disease, malignancies and also
depression. The investigators believe that sport is as effective supportive tool in
improving quality of life in IBD patients. But data is lacking with regard to controlled
randomized clinical trials. Because of the small amount of data available the investigators
considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate
exercise. The investigators further suspect that these patients improve their quality of
life compared with patients in the control group.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | November 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - >18 years - proven colitis ulcerosa (CU) - proven crohns disease (CD) - diagnosis >= 1 year before start of the study - low or moderate disease activity Exclusion Criteria: - < 18 years - high disease activity - regular exercise > 2 hours per week - diagnosis of CU oder CD < 1 year before start of the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum rechts der Isar | München | Bayern |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität München |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of life | 10 weeks | No | |
| Secondary | disease activity | 10 weeks | No |